BETAMETHASONE DIPROPIONATE cream, augmented

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)

Available from:

Proficient Rx LP

INN (International Name):

BETAMETHASONE DIPROPIONATE

Composition:

BETAMETHASONE 0.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Betamethasone dipropionate cream (augmented) is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older. Betamethasone dipropionate cream (augmented), is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

Product summary:

Betamethasone Dipropionate Cream USP (Augmented*), 0.05%, is supplied as follows: Store between 2° and 30°C (36° and 86°F). E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 I2265B R09/11 #59

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETAMETHASONE DIPROPIONATE- BETAMETHASONE DIPROPIONATE CREAM,
AUGMENTED
PROFICIENT RX LP
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BETAMETHASONE DIPROPIONATE
CREAM USP (AUGMENTED*), 0.05%
(POTENCY EXPRESSED AS BETAMETHASONE)
* VEHICLE AUGMENTS THE PENETRATION OF THE STEROID.
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION:
Betamethasone dipropionate cream (augmented) contains betamethasone
dipropionate, USP, a synthetic
adrenocorticosteroid, for dermatologic use in an emollient base.
Betamethasone, an analog of
prednisolone, has a high degree of corticosteroid activity and a
slight degree of mineralocorticoid
activity. Betamethasone dipropionate is the 17,21-dipropionate ester
of betamethasone.
Chemically, betamethasone dipropionate is
9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-
diene-3,20-dione 17,21-dipropionate, with the empirical formula C
H FO , a molecular weight of
504.6, and the following structural formula:
Betamethasone dipropionate is a white to creamy white, odorless
crystalline powder, insoluble in
water.
Each gram of Betamethasone Dipropionate Cream USP (Augmented*), 0.05%
contains: 0.643 mg
betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone)
in an emollient cream base of
purified water, USP; chlorocresol NF; white petrolatum, USP; white
wax, NF; cyclomethicone; sorbitol
solution, USP; glyceryl monooleate; propylene glycol, USP;
ceteareth-30; carbomer 940, NF; and
sodium hydroxide NF.
CLINICAL PHARMACOLOGY:
The corticosteroids are a class of compounds comprising steroid
hormones secreted by the adrenal
cortex and their synthetic analogs. In pharmacologic doses,
corticosteroids are used primarily for their
anti-inflammatory and/or immunosuppressive effects.
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Topical corticosteroids, such as betamethasone dipropionate, are
effective in the treatment of
corticosteroid-responsive dermatoses primarily because of their
anti-inflammatory, anti-pruritic, and
vasoconstrictive actions. However, while the physiologic,
pharmacologic, and clinical effects of the
corticosteroids are well k